In the nonobese diabetic mouse (NOD) model for the human autoimmune insulin-dependent diabetes mellitus, we have documented that one-time administration of Bacillus Calmette-Guerin (BCG) prevents as well as reverses diabetes, and that this protective effect appears to be life-long. The goal of this double-blind, random-assignment, placebo-controlled clinical study is to determine the safety and efficacy of BCG vaccination when used to induce clinical remission in new-onset human insulin-dependent diabetes mellitus.